Core Viewpoint - The company announced that its internally developed Claudin18.2 antibody-drug conjugate (ADC) ATG-022 has received breakthrough therapy designation from the China National Medical Products Administration (NMPA) for the treatment of patients with CLDN18.2 positive, HER2 negative unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma who have previously received at least two treatments [1] Group 1 - The breakthrough therapy designation is a significant regulatory milestone for the company, indicating the potential of ATG-022 in addressing unmet medical needs in gastric cancer treatment [1] - The targeted patient population includes those with specific biomarkers (CLDN18.2 positive and HER2 negative), which may enhance the drug's efficacy and marketability [1] - The designation may expedite the development and review process for ATG-022, potentially leading to earlier market access [1]
德琪医药-B：ATG-022就治疗胃癌/胃食管结合部腺癌获授予突破性治疗药物认定